Medical Device Manufacturer · US , Newark , DE

Siemens Healthcare Diagnostics

92 submissions · 92 cleared · Since 2008
92
Total
92
Cleared
0
Denied

Siemens Healthcare Diagnostics — FDA 510(k) Submissions

Siemens Healthcare Diagnostics has submitted 92 FDA 510(k) premarket notifications since 2008, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Calibrator, Multi-analyte Mixture, System, Test, Radioallergosorbent (rast) Immunological, Calibrator, Secondary, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
K243570 · JLW Radioimmunoassay,... · Chemistry
Apr 2025 158d
ADVIA 2120i, ADVIA 2120
K162977 · GKZ Counter, Differential Cell · Hematology
Aug 2017 289d
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG System, Test, Vitamin D · Chemistry
Mar 2017 212d
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
K161954 · JGS Electrode, Ion Specific,... · Chemistry
Mar 2017 234d
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
K162538 · JIT Calibrator, Secondary · Chemistry
Nov 2016 66d
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · GJS Test, Time, Prothrombin · Hematology
Sep 2016 442d
Dimension Tacrolimus Flex? Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
K150168 · MLM Enzyme Immunoassay,... · Toxicology
Nov 2015 282d
Dimension Vista MMB Assay
K143720 · JHY Colorimetric Method, Cpk... · Chemistry
Sep 2015 263d
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
K140790 · JIX Calibrator, Multi-analyte... · Chemistry
Jun 2015 441d
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132 · JJX Single (specified)... · Chemistry
Apr 2015 82d
IMMULITE 2000 CEA Calibration Verification Material
K143639 · JJX Single (specified)... · Immunology
Jan 2015 32d
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
K140717 · KQO Automated Urinalysis System · Chemistry
Nov 2014 242d
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
K133512 · CDD Radioassay, Vitamin B12 · Chemistry
Jan 2014 48d
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
K122539 · CHL Electrode Measurement,... · Chemistry
Apr 2013 241d
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · JIT Calibrator, Secondary · Chemistry
Apr 2013 22d
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · CEW Radioimmunoassay,... · Chemistry
Mar 2013 258d
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
K123677 · JIF Enzymatic Method, Ammonia · Chemistry
Mar 2013 97d
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · JIF Enzymatic Method, Ammonia · Chemistry
Feb 2013 112d
DIMENSION CHEMISTRY III CALIBRATORY
K123321 · JIX Calibrator, Multi-analyte... · Chemistry
Feb 2013 112d
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
K122323 · CJO Alpha-naphthyl Phosphate,... · Chemistry
Aug 2012 27d
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
K121907 · CJO Alpha-naphthyl Phosphate,... · Chemistry
Jul 2012 24d
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · KHP Acid, Lactic, Enzymatic... · Chemistry
May 2012 184d
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
K102644 · GKZ Counter, Differential Cell · Hematology
Nov 2011 435d
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · JJE Analyzer, Chemistry... · Chemistry
Nov 2011 46d
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
K112142 · NDW Assay, Porphyrin,... · Chemistry
Nov 2011 101d

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